This invention relates to a process for extracting endotoxin adhered to or adsorbed on a surface of a solid.
Endotoxins are lipopolysaccharides present mainly in cell walls of Gram-negative bacteria and are known as pyrogens. Therefore, the measurement of endotoxin concentration in a sample is one important measurement in the fields of medical science, pharmacology and microbiology.
As to medical devices such as syringes and catheters, in order to prevent penetration of pyrogens into human bodies, it is necessary to severely control contamination due to endotoxins. Many medical devices are made from various synthetic resins, glass, metals and natural fibers. Among these materials, some are known to adsorb endotoxin thereon. In order to measure the degree of contamination of these materials with endotoxin, these materials are generally rinsed with water or a physiological saline to extract the endotoxin adhered to surfaces thereof. Then, the amount of endotoxin in the extract is measured. According to the above-mentioned method, there is a fear of not completely extracting the endotoxin adhered to or adsorbed on surfaces of solids, resulting in causing extraction of endotoxin, which has not been extracted with the water or physiological saline, when contacted with blood and drugs.
Therefore, it is earnestly desired to establish a process for extracting endotoxin from surfaces of solids effectively, and a process for measuring the degree of contamination of such materials with endotoxin precisely. At the same time, it is also earnestly desired to provide a process for effectively cleaning containers and devices contaminated with endotoxin.